tDCS for Cancer-Related Fatigue and Weakness

NCT07159100 | Not Yet Recruiting Early Phase 1 FDA Device

• 1 other identifier: R 1012-18
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study investigates the effectiveness of non-invasive brain stimulation (tDCS) in alleviating cancer-related fatigue (CRF) and muscle weakness. Using a randomized, double-blind crossover design, participants perform fatiguing muscle tasks with and without tDCS, and outcomes include task endurance, maximal voluntary contraction force, and neuromuscular markers. Neural mechanisms will be assessed via EEG, TMS, and MRI.

Conditions

Cancer-related Fatigue; Neuromodulation

Keywords

tDCS; Cancer-related fatigue; neuromodulation

Outcome Measures

Primary Outcomes (2)

• Fatigue task duration

  Duration (in seconds) that participants are able to maintain a submaximal isometric contraction (20-40% of maximal voluntary contraction) during a fatigue-inducing task, performed with and without transcranial direct current stimulation (tDCS).

  Immediately post-intervention in each experimental session.

• Muscle Strength

  Peak muscle force (in Newtons) generated during a maximal voluntary contraction (MVC) of the arm muscles, assessed immediately before and after the fatiguing isometric contraction task. Comparison is made across active tDCS and sham conditions to determine the acute effects of neuromodulation on post-fatigue strength. Force is measured using a calibrated force sensor.

  Immediately after each stimulation session

Secondary Outcomes (4)

• EMG root mean squared amplitude

  Immediately after each stimulation session

• Interpolated Twitch Force (Peripheral Fatigue Index)

  Immediately after each stimulation session

• Motor Evoked Potential (MEP) Amplitude

  Immediately after each stimulation session

• EEG Functional Connectivity

  Immediately after each stimulation session

Study Arms (2)

Active tDCS

EXPERIMENTAL

1.5-2.0 mA stimulation over motor cortex during fatigue task.

Device: Active tDCS + elbow flexion exercise

Sham tDCS

SHAM COMPARATOR

Stimulation for 30 seconds with ramping to mimic active sensation.

Drug: Sham tDCS + elbow flexion exercise

Interventions

Active tDCS + elbow flexion exercise DEVICE

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 20-30 minutes, either before or during a sustained submaximal isometric contraction task designed to induce fatigue. tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current. The intervention is unique as the target population is cancer survivors with persistent fatigue \>6 months post-treatment. Also, the tDCS is combined with neurophysiological assessments, including EMG, TMS, EEG, and MRI, to provide neurophysiological evidence of acute effects.

Also known as: Active tDCS

Active tDCS

Sham tDCS + elbow flexion exercise DRUG

Participants will receive anodal tDCS targeting motor-related cortical areas using either traditional sponge-based or high-definition (HD)-tDCS configurations. The intervention is delivered at 1.5-2.0 mA for 30 seconds to mimic the sensation of active tDCS (20 minutes long), either before or during a sustained submaximal isometric contraction task designed to induce fatigue. tDCS will be administered in a counterbalanced crossover design, where each participant completes both active stimulation and sham stimulation conditions in separate sessions spaced at least one week apart. Sham stimulation mimics the sensory effects of active tDCS (30-second ramp-up and down) without delivering sustained current.

Sham tDCS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History of epilepsy or unprovoked seizures
• Family history of epilepsy (father, mother, children, siblings with diagnosis of epilepsy)
• Active migraine headaches
• Past or current history of treated tinnitus or severe hearing problems
• Implanted medical devices (pacemakers, defibrillators, medical pump, implanted brain stimulator, aneurysm clip, carotid or cerebral stents, central venous catheter, non-removable hearing aids)
• Damage to the skin on the scalp
• History of mental illness (schizophrenia, anxiety, major depression, manic disorders)
• Tattoo with metal based ink in the head or neck
• Currently taking or withdrawing from any central nervous system active medication (stimulants, anticonvulsants, antidepressants, psychotropic medications).
• Pregnant as determined by a Pregnancy test for non-menopausal (no menstruation for at least 1 year) women younger than 55 years (for TMS and fMRI only).
• Suffer from claustrophobia (fear of confined spaces)
• Prior injury to the eye involving a metallic object or fragment (e.g., metallic slivers, shavings, foreign body, etc.)?
• Presence or prior injury by a metallic object, or foreign body or metallic fragment (e.g., BB, bullet, shrapnel, etc.)
• Currently or former metal worker (welder, machinist, etc.)
• Implanted electrical devices (e.g. pacemakers, defibrillators or ICD)

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Study Officials

• Guang Yue, PhD

  Kessler Foundation

  STUDY DIRECTOR

Central Study Contacts

Leighann Martinez

CONTACT

973.324.3557; LMartinez@kesslerfoundation.org

Vikram Shenoy Handiru, PhD

CONTACT

9733243578; vshenoy@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 8, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

US (1)